None listed
Conditions
Brief summary
The primary objective of this pilot randomised controlled trial is to assess the feasibility and acceptability of a new, 5-week, group-based online-delivered stress management program for Australian with breast and colorectal cancer. Who is it for? You may be eligible for this study if you are an adult diagnosed with breast or colorectal cancer (Stage I, II, or III) and are currently undergoing cancer treatment (e.g., surgery, chemotherapy, radiotherapy, hormone therapy). Study details Participants will be randomly assigned to either the intervention group or the control group. Participants in the intervention group will attend 5 weekly, 100-minute sessions delivered online through Zoom. They will also have access to a study website, which will contain summaries of the sessions and guidance on relaxation techniques. Participants in the control group will receive information on support networks they can access, and following completion of the study period, will receive access to the study website. It is hoped that the findings from this study will help researchers evaluate the feasibility and acceptability of an online stress management program for cancer patients and guide the design of future larger trials.
Interventions
Cognitive Behavioural Stress Management (CBSM) intervention. Participants in the intervention group will attend 5 weekly, 100-minute sessions delivered online through Zoom. Each session will be divided into three segments: i) an initial discussion (20 minutes), ii) cognitive behavioural therapy (CBT) components (40 minutes), and iii) relaxation techniques (40 minutes). Each group will include 4-5 people. First session: stress definition, appraisal process explanation, and 7 groups of progressive
Cognitive Behavioural Stress Management (CBSM) intervention. Participants in the intervention group will attend 5 weekly, 100-minute sessions delivered online through Zoom. Each session will be divided into three segments: i) an initial discussion (20 minutes), ii) cognitive behavioural therapy (CBT) components (40 minutes), and iii) relaxation techniques (40 minutes). Each group will include 4-5 people. First session: stress definition, appraisal process explanation, and 7 groups of progressive muscle relaxation. Second session: Automatic thoughts, cognitive distortions, deep breathing, 4 groups of progressive muscle relaxation, and guided imagery "Beach Scene". Third session: coping strategies, softening, deep breathing, and guided imagery "Special Place Imagery". Fourth session: Interpersonal Support and anger management, progressive muscle relaxation, and guided imagery "Light imagery". Fifth session: assertiveness training and meditation. After attending the first session, participants will have access to a website where information about the content of each week’s session is shared, as well as a recording to practice the relaxation technique learned during each session. Participants will be encouraged to practice between sessions to enhance the effectiveness of the relaxation techniques and reinforce these new skills. Participants are encouraged to practice at least one relaxation technique between sessions. Each practice session typically lasts around 20 minutes. However, engaging in this practice is entirely up to the participant; choosing not to do so will not result in exclusion from the program. Additionally, the program’s website provides supplementary materials (e.g., slide presentations) summarising the content discussed in each session. These resources are intended to support participants who may experience side effects from cancer treatment and, therefore, require more time to focus on specific topics. The use of these materials is optional and depends entirely on each participant’s preferences and needs. The intervention is delivered by A.V., a PhD student who has received training and ongoing support from the developer of the CBSM program. As this is not a therapeutic program, the facilitator is not required to be a registered psychologist or psychotherapist. Adherence to the intervention will be assessed through a combination of attendance records and engagement with program materials. Specifically, the facilitator will record participants' attendance at each of the five weekly online group sessions. If a participant is unable to attend a session, they will be offered a shorter individual session to review the content they missed. This approach is intended to maintain intervention fidelity and support the participant in rejoining the group the following week. Usage data from the program website will be monitored at the beginning of each session to assess participants' interaction with the intervention content. If a participant is not engaging with the materials as expected, the facilitator will follow up to discuss any barriers they may be experiencing and explore potential solutions to support their continued involvement
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) a diagnosis of breast or colorectal cancer (Stage I, II or III), b) aged 18 years old or older, c) currently receiving any cancer treatment (e.g., surgery, chemotherapy, radiotherapy, hormone therapy), d) having access to an internet-connected device (e.g., computer, tablet PC), e) capacity to consent to the study, f) willing to participate in a 5-week group program and engage in program activities, g) able to read and speak English.
Exclusion criteria
a) severe cognitive impairment, thus, unable to provide consent, b) a previous history of cancer or multiple primary cancers, c) recurrence of cancer, d) receiving non-curative treatment.
Outcome results
None listed